TY - JOUR
T1 - Molecular response and quality of life in chronic myeloid leukemia patients treated with intermittent TKIs: First interim analysis of OPTkIMA study
AU - Malagola, Michele
AU - Iurlo, Alessandra
AU - Abruzzese, Elisabetta
AU - Bonifacio, Massimiliano
AU - Stagno, Fabio
AU - Binotto, Gianni
AU - D’Adda, Mariella
AU - Lunghi, Monia
AU - Crugnola, Monica
AU - Ferrari, Maria Luisa
AU - Lunghi, Francesca
AU - Castagnetti, Fausto
AU - Rosti, Gianantonio
AU - Lemoli, Roberto M.
AU - Sancetta, Rosaria
AU - Coppi, Maria Rosaria
AU - Corsetti, Maria Teresa
AU - Rege Cambrin, Giovanna
AU - Romano, Atelda
AU - Tiribelli, Mario
AU - Russo Rossi, Antonella
AU - Russo, Sabina
AU - Aprile, Lara
AU - Gandolfi, Lisa
AU - Farina, Mirko
AU - Bernardi, Simona
AU - Polverelli, Nicola
AU - Roccaro, Aldo M.
AU - De Vivo, Antonio
AU - Baccarani, Michele
AU - Russo, Domenico
N1 - Publisher Copyright:
© 2021 The Authors. Cancer Medicine published by John Wiley & Sons Ltd.
Copyright:
Copyright 2021 Elsevier B.V., All rights reserved.
PY - 2021
Y1 - 2021
N2 - Background: Intermittent treatment with TKIs is an option for the great majority (70%–80%) of CML patients who do not achieve a stable deep molecular response and are not eligible for treatment discontinuation. For these patients, the only alternative is to assume TKI continuously, lifelong. Methods: The Italian phase III multicentric randomized OPTkIMA study started in 2015, with the aim to evaluate if a progressive de-escalation of TKIs (imatinib, nilotinib, and dasatinib) is able to maintain the molecular response (MR3.0) and to improve Health Related Quality of Life (HRQoL). Results: Up to December 2018, 166/185 (90%) elderly CML patients in stable MR3.0/MR4.0 completed the first year of any TKI intermittent schedule 1 month ON and 1 month OFF. The first year probability of maintaining the MR3.0 was 81% and 23.5% of the patients who lost the molecular response regained the MR3.0 after resuming TKI continuously. Patients’ HRQoL at baseline was better than that of matched peers from healthy population. Women was the only factor independently associated with worse baseline HRQoL (p > 0.0001). Overall, global HRQoL worsened at 6 (p < 0.001) but returned to the baseline value at 12 months and it was statistically significantly worse in women (p = 0.001). Conclusions: De-escalation of any TKI by 1 month ON/OFF schedule maintains the MR3.0/MR4.0 in 81% of the patients during the first 12–24 months. No patients progressed to accelerated/blastic phase, all the patients (23.5%) losing MR3.0 regained the MR3.0 and none suffered from TKI withdrawn syndrome. The study firstly report on HRQoL in elderly CML patients moving from a continuous daily therapy to a de-escalated intermittent treatment.
AB - Background: Intermittent treatment with TKIs is an option for the great majority (70%–80%) of CML patients who do not achieve a stable deep molecular response and are not eligible for treatment discontinuation. For these patients, the only alternative is to assume TKI continuously, lifelong. Methods: The Italian phase III multicentric randomized OPTkIMA study started in 2015, with the aim to evaluate if a progressive de-escalation of TKIs (imatinib, nilotinib, and dasatinib) is able to maintain the molecular response (MR3.0) and to improve Health Related Quality of Life (HRQoL). Results: Up to December 2018, 166/185 (90%) elderly CML patients in stable MR3.0/MR4.0 completed the first year of any TKI intermittent schedule 1 month ON and 1 month OFF. The first year probability of maintaining the MR3.0 was 81% and 23.5% of the patients who lost the molecular response regained the MR3.0 after resuming TKI continuously. Patients’ HRQoL at baseline was better than that of matched peers from healthy population. Women was the only factor independently associated with worse baseline HRQoL (p > 0.0001). Overall, global HRQoL worsened at 6 (p < 0.001) but returned to the baseline value at 12 months and it was statistically significantly worse in women (p = 0.001). Conclusions: De-escalation of any TKI by 1 month ON/OFF schedule maintains the MR3.0/MR4.0 in 81% of the patients during the first 12–24 months. No patients progressed to accelerated/blastic phase, all the patients (23.5%) losing MR3.0 regained the MR3.0 and none suffered from TKI withdrawn syndrome. The study firstly report on HRQoL in elderly CML patients moving from a continuous daily therapy to a de-escalated intermittent treatment.
KW - chronic myeloid leukaemia
KW - intermittent
KW - quality of life
KW - tyrosine kinase inhibitor
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U2 - 10.1002/cam4.3778
DO - 10.1002/cam4.3778
M3 - Article
AN - SCOPUS:85100882225
VL - 10
SP - 1726
EP - 1737
JO - Cancer Medicine
JF - Cancer Medicine
SN - 2045-7634
IS - 5
ER -